On Sept. 23, 2026, SystImmune announces the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for SI-B037, a bispecific antibody targeting immunosuppression and other synergistic mechanisms.

The FDA clearance marks SystImmune’s first IND application utilizing New Approach Methodologies (NAMs) as part of its integrated nonclinical safety and translational assessment package. It also underscores the company’s role at the forefront of the global paradigm shift toward modern, human-centric, non-animal testing alternatives encouraged by regulatory authorities worldwide.

SystImmune is a clinical-stage biotechnology company located in Redmond, WA. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.